Evaluation of the LivIQ Leadless Pacemaker System for Patients Requiring Ventricular Pacing

What this Trial Is About

Researchers are evaluating the LivIQ leadless pacemaker system in patients who need ventricular pacing according to Class I or II guidelines. This study aims to confirm the devices safety and performance, including a sub-study focused on its ability to maintain atrioventricular synchrony. The trial is open-label, prospective, single-arm, and conducted internationally across multiple centers. Participants will receive the LivIQ leadless pacemaker, implanted directly into the right ventricle. The study includes a main phase and an integrated atrioventricular synchrony sub-study, where specific heart rhythm data is collected at 1 and 6 months. Follow-ups occur at implant, pre-hospital discharge, 1, 3, 6, and 12 months, then every 6 months until market approval, with a remote 24-month visit after U.S. approval. Participants undergo regular on-site examinations and monitoring including device performance checks and health questionnaires. The study measures freedom from serious device-related effects, pacing adequacy, sensing performance, quality of life, battery longevity, and survival at 24 months. Participants are expected to complete all scheduled visits over the study duration, which may extend beyond two years.

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System